Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT01435603
Status:
COMPLETED
Last Update Posted:
2018-04-27
First Post:
2011-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intervening in Diabetes With Healthy Eating, Activity, and Linkages To Healthcare - The I-D-HEALTH Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emily.anderson1@northwestern.edu', 'phone': '312-503-3359', 'title': 'Research Project Manager', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Over the 1 year measurement period, we experienced significant loss to follow-up in this diverse, predominantly low-income sample. We were only able to measure the primary outcome, body weight, on 257 of 331 participants at the 12 month visit.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Lifestyle Advice', 'description': "Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).\n\nStandard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months.", 'otherNumAtRisk': 167, 'deathsNumAtRisk': 167, 'otherNumAffected': 0, 'seriousNumAtRisk': 167, 'deathsNumAffected': 1, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Advice Plus Lifestyle Intervention', 'description': 'Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant\'s usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.\n\nStandard Lifestyle Advice: See "Standard Lifestyle Advice" arm.\n\nAdvice Plus Lifestyle Intervention: Standard clinical education offered by the participant\'s usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.', 'otherNumAtRisk': 164, 'deathsNumAtRisk': 164, 'otherNumAffected': 0, 'seriousNumAtRisk': 164, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'seriousEvents': [{'term': 'Hypoglycemia (severe: admitted to hospital, emergency room, or needed assistance by other person)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart attack (myocardial infarction)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Balloon angioplasty or Stenting of coronary arteries (Percutaneous transluminal coronary angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke (transient ischemic attack, cerebral ischemia/hemorrhage, or cerebrovascular accident)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arryhythmia (atrial fibrillation or flutter)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Lifestyle Advice', 'description': "Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).\n\nStandard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months."}, {'id': 'OG001', 'title': 'Advice Plus Lifestyle Intervention', 'description': 'Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant\'s usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.\n\nStandard Lifestyle Advice: See "Standard Lifestyle Advice" arm.\n\nAdvice Plus Lifestyle Intervention: Standard clinical education offered by the participant\'s usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '4.05', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '4.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.273', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': '(Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed weight measurements at the baseline and 12 month exam'}, {'type': 'SECONDARY', 'title': 'Incremental Costs', 'timeFrame': '6, 12, and 24 months', 'description': 'The study will capture direct medical, direct non-medical, and indirect costs from individual participants. Mean changes in these costs will be compared across randomized study arms.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in Health State Utility', 'timeFrame': 'Baseline to 6,12, and 24 months', 'description': 'The study collects individual participant survey data that will include the Medical Outcomes Study Short Form-12 health-related quality of life questionnaire. Responses from the questionnaire are used to construct a validated numerical score that expresses global health-related quality of life across a range of 0 (death) to 1 (perfect health). Changes in this indicator will be evaluated.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percent Change in Body Weight', 'timeFrame': 'Baseline to 6 and 24 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percent Change in Blood Total Cholesterol', 'timeFrame': 'Baseline to 6, 12, and 24 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percent Change in A1c', 'timeFrame': 'Baseline to 6, 12, and 24 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percent Change in Blood Pressure', 'timeFrame': 'Baseline to 6, 12, and 24 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percent Change in Dietary Composition', 'timeFrame': 'Baseline to 6, 12, and 24 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percent Change in Physical Activity', 'timeFrame': 'Baseline to 6, 12, and 24 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Lifestyle Advice', 'description': "Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).\n\nStandard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months."}, {'id': 'FG001', 'title': 'Advice Plus Lifestyle Intervention', 'description': 'Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant\'s usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.\n\nStandard Lifestyle Advice: See "Standard Lifestyle Advice" arm.\n\nAdvice Plus Lifestyle Intervention: Standard clinical education offered by the participant\'s usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '129'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '35'}]}]}], 'preAssignmentDetails': 'Potential participants were prescreened on the phone and attended a baseline visit for further screening and enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Lifestyle Advice', 'description': "Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).\n\nStandard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months."}, {'id': 'BG001', 'title': 'Advice Plus Lifestyle Intervention', 'description': 'Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant\'s usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.\n\nStandard Lifestyle Advice: See "Standard Lifestyle Advice" arm.\n\nAdvice Plus Lifestyle Intervention: Standard clinical education offered by the participant\'s usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '57.1', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '56.9', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-27', 'studyFirstSubmitDate': '2011-09-12', 'resultsFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2011-09-15', 'lastUpdatePostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-27', 'studyFirstPostDateStruct': {'date': '2011-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Body Weight', 'timeFrame': 'Baseline to 12 months', 'description': '(Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss.'}], 'secondaryOutcomes': [{'measure': 'Incremental Costs', 'timeFrame': '6, 12, and 24 months', 'description': 'The study will capture direct medical, direct non-medical, and indirect costs from individual participants. Mean changes in these costs will be compared across randomized study arms.'}, {'measure': 'Changes in Health State Utility', 'timeFrame': 'Baseline to 6,12, and 24 months', 'description': 'The study collects individual participant survey data that will include the Medical Outcomes Study Short Form-12 health-related quality of life questionnaire. Responses from the questionnaire are used to construct a validated numerical score that expresses global health-related quality of life across a range of 0 (death) to 1 (perfect health). Changes in this indicator will be evaluated.'}, {'measure': 'Percent Change in Body Weight', 'timeFrame': 'Baseline to 6 and 24 months'}, {'measure': 'Percent Change in Blood Total Cholesterol', 'timeFrame': 'Baseline to 6, 12, and 24 months'}, {'measure': 'Percent Change in A1c', 'timeFrame': 'Baseline to 6, 12, and 24 months'}, {'measure': 'Percent Change in Blood Pressure', 'timeFrame': 'Baseline to 6, 12, and 24 months'}, {'measure': 'Percent Change in Dietary Composition', 'timeFrame': 'Baseline to 6, 12, and 24 months'}, {'measure': 'Percent Change in Physical Activity', 'timeFrame': 'Baseline to 6, 12, and 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prevention & Control', 'Hyperglycemia', 'Obesity', 'Diabetes Mellitus', 'Cost Benefit Analysis'], 'conditions': ['Diabetes Mellitus', 'Hyperglycemia', 'Obesity', 'Glucose Metabolism Disorders', 'Metabolic Diseases', 'Endocrine System Diseases', 'Overnutrition', 'Nutrition Disorders', 'Overweight', 'Body Weight', 'Signs and Symptoms']}, 'referencesModule': {'references': [{'pmid': '26611433', 'type': 'RESULT', 'citation': 'Liss DT, Finch EA, Gregory DL, Cooper A, Ackermann RT. Design and participant characteristics for a randomized effectiveness trial of an intensive lifestyle intervention to reduce cardiovascular risk in adults with type 2 diabetes: The I-D-HEALTH study. Contemp Clin Trials. 2016 Jan;46:114-121. doi: 10.1016/j.cct.2015.11.016. Epub 2015 Dec 2.'}, {'pmid': '29596950', 'type': 'DERIVED', 'citation': 'Liss DT, Finch EA, Cooper A, Sheth A, Tejuosho AD, Lancki N, Ackermann RT. One-year effects of a group-based lifestyle intervention in adults with type 2 diabetes: A randomized encouragement trial. Diabetes Res Clin Pract. 2018 Jun;140:36-44. doi: 10.1016/j.diabres.2018.03.030. Epub 2018 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare ways of giving advice and providing support to improve diet and physical activity in adult primary care patients with elevated body mass index and dysglycemia.', 'detailedDescription': 'This is a randomized comparative effectiveness trial to evaluate the health and economic effects of a community-based intensive lifestyle intervention for adult primary care patients with elevated body mass index and dysglycemia (either type 2 diabetes or pre-diabetes). The study will use qualitative and quantitative methods to assess reach, effectiveness, costs, adoption, implementation, and maintenance of a clinical-community partnership to offer intensive lifestyle intervention resources to eligible adult primary care patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18 years of age or older, AND\n2. Body-mass index of ≥ 24 kg/m2, AND\n3. Documented Dysglycemia: Either by verification of laboratory test (Fasting Plasma Glucose 100-125 mg/dl OR 2-hour Post-challenge Plasma Glucose 140-199 mg/dl OR A1c 5.7%-10.9%) OR confirmation of Type 2 diabetes mellitus by self-report with verification\n\nExclusion Criteria (any of the following):\n\nDiseases/Conditions that could limit lifespan and/or increase risk with a lifestyle intervention:\n\n1. Significant cardiovascular disease:\n\n * Uncontrolled hypertension: systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>105 mmHg\n * A1c \\> 10.9%\n * Heart attack, stroke, or transient ischemic attack (TIA) in the past 6 months\n * Chest pain, dizziness, or fainting with physical exertion\n2. Lung disease:\n\n * Chronic obstructive airways disease or asthma requiring home oxygen\n3. Pregnancy\n4. Any other known condition that could limit ability to become physically active or limit life span to \\<5 years\n\nExclusions related to metabolism:\n\n1. Use of medications known to produce hyperglycemia\n2. Known disease leading to abnormal glucose metabolism, other than diabetes mellitus, including Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis\n\nExclusion for conditions or behaviors likely to affect the conduct of the study:\n\n1. Unable or unwilling to provide informed consent\n2. Unable to communicate with the pertinent research study staff\n3. Unable to read written English or Spanish"}, 'identificationModule': {'nctId': 'NCT01435603', 'acronym': 'I-D-HEALTH', 'briefTitle': 'Intervening in Diabetes With Healthy Eating, Activity, and Linkages To Healthcare - The I-D-HEALTH Study', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Community Translation of a Lifestyle Intervention to Improve Health in Diabetes', 'orgStudyIdInfo': {'id': 'STU00056501'}, 'secondaryIdInfos': [{'id': 'R18DK083941', 'link': 'https://reporter.nih.gov/quickSearch/R18DK083941', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Lifestyle Advice', 'description': "Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).", 'interventionNames': ['Behavioral: Standard Lifestyle Advice']}, {'type': 'EXPERIMENTAL', 'label': 'Advice Plus Lifestyle Intervention', 'description': "Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.", 'interventionNames': ['Behavioral: Standard Lifestyle Advice', 'Behavioral: Advice Plus Lifestyle Intervention']}], 'interventions': [{'name': 'Standard Lifestyle Advice', 'type': 'BEHAVIORAL', 'otherNames': ['Brief Lifestyle Advice'], 'description': "Standard clinical education is offered routinely by the participant's usual primary care team. Primary care teams receive educational outreach visits and are provided with clinical recommendations for lifestyle and cardiovascular risk factor management. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months.", 'armGroupLabels': ['Advice Plus Lifestyle Intervention', 'Standard Lifestyle Advice']}, {'name': 'Advice Plus Lifestyle Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Plan Ahead Lifestyle Intervention', 'Intensive Lifestyle Intervention'], 'description': "Standard clinical education offered routinely by the participant's usual primary care team. Primary care teams receive educational outreach visits for lifestyle and cardiovascular risk factor management. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.", 'armGroupLabels': ['Advice Plus Lifestyle Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'YMCA of Metro Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'McGaw YMCA', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}], 'overallOfficials': [{'name': 'Ronald T. Ackermann, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University (Illinois)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Ronald Ackermann', 'investigatorAffiliation': 'Northwestern University'}}}}